Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /

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On September 15, 2008, the National Academies held the workshop "Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches". The workshop was planned and organized by an ad hoc planning committee made up of members of the...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores Corporativos: National Research Council (U.S.). Standing Committee on Biodefense at the U.S. Department of Defense, National Research Council (U.S.). Board on Life Sciences
Otros Autores: Fox, Jeffrey (Jeffrey L.), Shelton-Davenport, Marilee, Hook-Barnard, India
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, ©2010.
Temas:
Biological warfare > United States > Safety measures.
Monoclonal antibodies > Therapeutic use.
Drug approval > United States.
Vaccines > United States.
Vaccines.
Biological Warfare > prevention & control
Drug Approval
Antibodies, Monoclonal > therapeutic use
Vaccines
Guerre biologique > États-Unis > Sécurité > Mesures.
Anticorps monoclonaux > Emploi en thérapeutique.
Médicaments > Autorisation de mise sur le marché > États-Unis.
Vaccins > États-Unis.
Vaccins.
HISTORY > Military > Biological & Chemical Warfare.
Biological warfare > Safety measures
Drug approval
Monoclonal antibodies > Therapeutic use
United States
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction
  • TMTI case for versatile production platforms
  • Discussion of TMTI efforts
  • Platforms for large-scale monoclonal antibody production
  • Presentation by Brian Kelley
  • Presentation by Dane Zabriskie
  • Discussion
  • Suitability of platforms and supply needed
  • Reducing timeline
  • Manufacturing producation capacity
  • Regulatory issues
  • Platforms for vaccine production
  • Presentation by Dave Robinson
  • Discussion
  • Various platforms
  • Manufacturing facilities
  • Regulatory issues
  • Summary of key points.

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